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EC number: 700-762-0 | CAS number: -
Toxicity to birds
Administrative data
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline. The effects on embryonic development are investigated through direct application of the substance on the egg shell. A great number of eggs (65 per dose) were tested, which contributes to make the results statistically valid.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- long-term toxicity to birds: reproduction test
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No guideline. The effects on embryonic development are investigated through direct application of the substance on the egg shell. A great number of eggs (65 per dose) were tested, which contributes to make the results statistically valid.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in IUCLID Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Oil is applied on the surface of fertile eggs. Embryonic survival time, teratogenic potential and growth are evaluated.
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
No surrogate test material - Dose method:
- other: application onto egg shell
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and analysis of diet:
- No diet
- Test organisms (species):
- Anas platyrhynchos
- Details on test organisms:
- TEST ORGANISM
- Common name: Mallard duck
- Source: Commercial hatcheries: Whistling WIngs, Hanover, Ill., and Truslow Farms, Chestertown, Md.
- Age at test initiation (mean and range, SD): Eggs (72hr of development) - Limit test:
- no
- Total exposure duration (if not single dose):
- 18 d
- Post exposure observation period:
- No post-exposure period
- No. of animals per sex per dose and/or stage:
- 65 eggs per dose. For sex ratio, see results.
- Control animals:
- yes, concurrent no treatment
- Nominal and measured doses / concentrations:
- 5µL per egg
- Details on test conditions:
- SUBSTANCE APPLICATION:
5µL of paraffin mixture were applied by microliter pipet to the shell surface just below the air space of upright eggs (72 hrs of development) and permitted to spread freely
NO. OF EGGS
- For negative control: 65
- For treated: 65
TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 37.5°C
- Relative humidity (%): 70 - Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: daily
- Remarks: all eggs were candled daily to determine mortality, and dead embryos were removed and examined.
EMBRYONIC WEIGHT
- Time schedule for examinations: All remaining eggs were opened on the 18th day of development and the embryos were removed and weighed.
- Remarks:
PATHOLOGY
- One half of the embryos were defeathered and placed in Bouin's solution for fixation and subsequent examination of soft tissues by the sectioning technique of Wilson (1965) and by dissection.
- The other half were cleared and staiend with alizarine red S according to the method described by Karnofsky (1965) for squeletal examination.
OTHER:
When removed from the shell, sex-ratios, crown-rump lengths, and beak lengths were recorded. - Details on reproductive parameters:
- The following parameters were examined per egg:
- Embryos viable
- Clinical signs of toxicity, abnormalities and mortality
OTHER:
- Embryonic growth: embryo weight, crown-rump length, beak length
- Sex ratio - Reference substance (positive control):
- no
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- Embryonic mortality
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- reproductive parameters
- Remarks:
- Embryo weight
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- reproductive parameters
- Remarks:
- Sex ratio
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: Development: crown-rump length
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: Development: beak length
- Repellency factors (if applicable):
- Not applicable
- Mortality and sub-lethal effects:
- For details on mortality and sub-lethal effects see Table no.1.
- Effects on reproduction:
- Effect on embryo development : see table1
- Results with reference substance (positive control):
- No reference substance
- Further details on results:
- No other details
- Reported statistics and error estimates:
- Embryonic weights, crown-rump lengths, and beak lengths were compared by one-way analysis of variance and Duncan's multiple range test. Survival data, sex distribution and numbers of embryos with one or more defects were compared by squared-chi analysis.
No statistical difference ws found between treated and control eggs for any invetigated parameter. - Validity criteria fulfilled:
- not applicable
- Conclusions:
- The application of paraffin mixture on the shell of Mallard duck egg has no effect on embryo development.
- Executive summary:
Paraffin mixture constitued of pentdecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphthalene, mixed in equal proportions, was applied on Mallard duck eggshell (5µL/egg). Embryonic survival, teratogenic potential and growth were evaluated.
No effect of oil application was noted, neither on embryo survival nor development.
Table 1. Effects of paraffin mixture (5 µL/egg) on Mallard duck embryos
|
Control |
Paraffin |
Number treated |
65 |
65 |
Percentage survival (Days 3-18) |
97 |
94 |
Sex ratio, M:F |
45:55 |
44:56 |
Embryonic Weight (g) |
||
Male |
15.72 ± 1.78 |
16.34 ± 1.49 |
Female |
15.75 ± 2.03 |
15.98 ± 1.58 |
Combined |
15.74 ± 1.90 |
16.14 ±1.54 |
Crown-rump length (mm) |
||
Male |
84.1 ± 3.7 |
84.9 ± 4.0 |
Female |
82.7 ± 3.7 |
83.4 ± 3.0 |
Combined |
82.8 ± 3.7 |
84.1 ± 3.5 |
Beak length (mm) |
||
Male |
13.2 ± 0.9 |
13.3 ± 0.5 |
Female |
13.1 ± 0.6 |
12.9 ± 0.6 |
Combined |
13.1 ± 0.7 |
13.1 ± 0.6 |
Percentage that were abnormal survivors |
4.8 |
3.3 |
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Embryotoxic effects of crude oil in Mallard Ducks and Chicks
- Author:
- Hoffman, D. J.
- Year:
- 1 978
- Bibliographic source:
- Toxicology and Applied Pharmacology 46: 183-190
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Oil is applied on the surface of fertile eggs. Embryonic survival time, teratogenic potential and growth are evaluated.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Paraffin mixture
- IUPAC Name:
- Paraffin mixture
- Details on test material:
- - Name of test material (as cited in study report): mixture of nine paraffin compounds, Paraffin mixture, Paraffin
- Substance type: Petroleum product
- Physical state: Liquid
- Composition of test material, percentage of components: in equal proportions: pentadecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8,-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphathalene
Constituent 1
- Specific details on test material used for the study:
- Details on properties of test surrogate or analogue material (migrated information):
No surrogate test material - Dose method:
- other: application onto egg shell
- Analytical monitoring:
- no
- Vehicle:
- no
- Details on preparation and analysis of diet:
- No diet
Test organisms
- Test organisms (species):
- Anas platyrhynchos
- Details on test organisms:
- TEST ORGANISM
- Common name: Mallard duck
- Source: Commercial hatcheries: Whistling WIngs, Hanover, Ill., and Truslow Farms, Chestertown, Md.
- Age at test initiation (mean and range, SD): Eggs (72hr of development)
Study design
- Limit test:
- no
- Total exposure duration (if not single dose):
- 18 d
- Post exposure observation period:
- No post-exposure period
- No. of animals per sex per dose and/or stage:
- 65 eggs per dose. For sex ratio, see results.
- Control animals:
- yes, concurrent no treatment
- Nominal and measured doses / concentrations:
- 5µL per egg
- Details on test conditions:
- SUBSTANCE APPLICATION:
5µL of paraffin mixture were applied by microliter pipet to the shell surface just below the air space of upright eggs (72 hrs of development) and permitted to spread freely
NO. OF EGGS
- For negative control: 65
- For treated: 65
TEST CONDITIONS (range, mean, SD as applicable)
- Temperature: 37.5°C
- Relative humidity (%): 70
Examinations
- Details on examinations and observations:
- MORTALITY / CLINICAL SIGNS
- Time schedule for examinations: daily
- Remarks: all eggs were candled daily to determine mortality, and dead embryos were removed and examined.
EMBRYONIC WEIGHT
- Time schedule for examinations: All remaining eggs were opened on the 18th day of development and the embryos were removed and weighed.
- Remarks:
PATHOLOGY
- One half of the embryos were defeathered and placed in Bouin's solution for fixation and subsequent examination of soft tissues by the sectioning technique of Wilson (1965) and by dissection.
- The other half were cleared and staiend with alizarine red S according to the method described by Karnofsky (1965) for squeletal examination.
OTHER:
When removed from the shell, sex-ratios, crown-rump lengths, and beak lengths were recorded. - Details on reproductive parameters:
- The following parameters were examined per egg:
- Embryos viable
- Clinical signs of toxicity, abnormalities and mortality
OTHER:
- Embryonic growth: embryo weight, crown-rump length, beak length
- Sex ratio - Reference substance (positive control):
- no
Results and discussion
Effect levelsopen allclose all
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- mortality
- Remarks:
- Embryonic mortality
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- reproductive parameters
- Remarks:
- Embryo weight
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- reproductive parameters
- Remarks:
- Sex ratio
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: Development: crown-rump length
- Duration (if not single dose):
- 18 d
- Dose descriptor:
- other: NOELR
- Effect level:
- 5 other: µL/egg
- Conc. / dose based on:
- test mat.
- Basis for effect:
- other: Development: beak length
- Repellency factors (if applicable):
- Not applicable
- Mortality and sub-lethal effects:
- For details on mortality and sub-lethal effects see Table no.1.
- Effects on reproduction:
- Effect on embryo development : see table1
- Results with reference substance (positive control):
- No reference substance
- Further details on results:
- No other details
- Reported statistics and error estimates:
- Embryonic weights, crown-rump lengths, and beak lengths were compared by one-way analysis of variance and Duncan's multiple range test. Survival data, sex distribution and numbers of embryos with one or more defects were compared by squared-chi analysis.
No statistical difference ws found between treated and control eggs for any invetigated parameter.
Any other information on results incl. tables
Table 1. Effects of paraffin mixture (5 µL/egg) on Mallard duck embryos
|
Control |
Paraffin |
Number treated |
65 |
65 |
Percentage survival (Days 3-18) |
97 |
94 |
Sex ratio, M:F |
45:55 |
44:56 |
Embryonic Weight (g) |
||
Male |
15.72 ± 1.78 |
16.34 ± 1.49 |
Female |
15.75 ± 2.03 |
15.98 ± 1.58 |
Combined |
15.74 ± 1.90 |
16.14 ±1.54 |
Crown-rump length (mm) |
||
Male |
84.1 ± 3.7 |
84.9 ± 4.0 |
Female |
82.7 ± 3.7 |
83.4 ± 3.0 |
Combined |
82.8 ± 3.7 |
84.1 ± 3.5 |
Beak length (mm) |
||
Male |
13.2 ± 0.9 |
13.3 ± 0.5 |
Female |
13.1 ± 0.6 |
12.9 ± 0.6 |
Combined |
13.1 ± 0.7 |
13.1 ± 0.6 |
Percentage that were abnormal survivors |
4.8 |
3.3 |
Applicant's summary and conclusion
- Validity criteria fulfilled:
- not applicable
- Conclusions:
- The application of paraffin mixture on the shell of Mallard duck egg has no effect on embryo development.
- Executive summary:
Paraffin mixture constitued of pentdecane, hexadecane, heptadecane, octadecane, nonadecane, 2,2,4,6,6-pentamethylheptane, 2,2,4,4,6,8,8-heptamethylnonane, 2,6,10,14-tetramethylpentadecane, and decahydronaphthalene, mixed in equal proportions, was applied on Mallard duck eggshell (5µL/egg). Embryonic survival, teratogenic potential and growth were evaluated.
No effect of oil application was noted, neither on embryo survival nor development.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
